Prevention of preterm birth: a randomized trial of vaginal compared to intramuscular progesterone.

MedLine Citation:

PMID:
23016508
Owner:
NLM
Status:
Publisher

Abstract/OtherAbstract:

Objective. To assess efficacy and tolerability of vaginal compared to intramuscular progesterone in reducing the rate of recurrent preterm birth before 34 weeks gestation. Design. Prospective randomized study. Setting. Obstetrics and Gynecology Department, Armed Forces Hospital Southern Region, Kingdom of Saudi Arabia. Sample. Five-hundred and eighteen patients with a prior history of preterm birth. Methods. Patients were randomized to receive either 90 mg of vaginal progesterone gel once daily or 250 mg of intramuscular progesterone weekly. Treatment began between 14 and 18 weeks gestation and continued until 36 complete weeks of gestation, delivery or the occurrence of premature rupture of membranes. Results. The baseline characteristics of the study participants were similar. Two-hundred and thirty eight (94.1%) patients in the vaginal group and 226 (90.8%) patients in the intramuscular group were compliant with their medications. Vaginal progesterone was associated with a lower percentage of deliveries before 34 weeks gestation than the intramuscular preparation (p = 0.02). This association was also observed at 28 and 32 weeks' gestation (p = 0.04). Side-effects were reported in 14.1% of patients in the intramuscular group, but in only 7.5% of patients in the vaginal group (p = 0.017). Conclusion. Vaginal progesterone was more effective than intramuscular progesterone for the prevention of preterm birth and had fewer side-effects.